Company Description
LabAnswer is the leading and largest laboratory informatics consultancy; combining science, laboratory, regulatory and information technologies. We have the people, processes, methodologies, IP and experience to deliver comprehensive laboratory informatics solutions.
LabAnswer has architected, implemented, deployed and/or supported hundreds of major scientific informatics systems across more than a thousand laboratories. LabAnswer performs significant laboratory automation work in pharmaceuticals, bio-pharmaceuticals, medical devices, forensics, and life sciences research laboratories spanning research, development and manufacturing/QC operations.
The LabAnswer team has a rare combination of laboratory science, IT, business and regulatory expertise. We specialize in helping companies strategize, architect, implement and support scientific data management and laboratory automation projects.
Job Description
At LabAnswer, we are looking for a leader to provide IT Project oversight for a laboratory systems validation project . This person must have at least 5 years of Project Management experience with managing LabWare LIMS projects.
Job Requirements
Serve as a IT Project Management and UAT resource for a LabWare LIMS implementation.
Set priorities for problem resolution
Develops relationships with vendors and 3rd party consultants
Communicate pertinent system information to site/project leadership as needed
Identify, document and communicate new site business requirements.
Coordinate implementation of new functionality or upgrades
Maintain a communication process with the other sites to maximize resource usage.
Maintain system related SOPs and create UAT scripts
Assist in working with business to identify data needs in new LIMS system
Provide strategic direction to the IT, Scientific, and Management teams based on combination of industry and technical knowledge
Assist in defining data migration requirements
Assist in creating and maintain SDLC documentation
Assist in working with Development team to implement and test accuracy and completeness of data migration
Contribute in all areas of system implementation including but not limited to vendor interaction, system compatibility, change control, qualification, deployment, and training
Work with project teams to ensure compliance with regulatory requirements such as FDA, CAP, CLIA, as well as internal policies and processes
Identify the optimum combination of applications that meet the requirements of disparate laboratory and business functions
Qualifications
A qualified candidate will possess:
Knowledge of LabWare LIMS
Experience with managing a laboratory systems validation project in a Pharmaceutical/R&D environment
Excellent verbal and written communication skills
Expert understanding of GMP
Demonstrated experience implementing enterprise data capture/management technologies
Ability to contribute to multiple projects for different business stakeholders
Experience implementing technology under a defined corporate and compliant methodology
Expert understanding of computer and application architecture, technology, and validation
Strong analytical and problem solving skills
Education:
Bachelor Degree in a related discipline and five+ years of project management, systems implementation and analysis experience. Emphasis should be on laboratory tools for R&D or Quality groups of an FDA regulated environment.
Additional Information
We offer comprehensive benefits to regular fulltime employees including but not limited to:
Unlimited ceiling for professional growth opportunities within LabAnswer
You will also have opportunities to take advantage of training programs to advance your career; our extensive online library includes an assortment of technical and professional training tools and resources
Opportunities to work across a variety of industries (Pharmaceutical, Medical Device, Consumer Products, Energy, Environmental, Forensics, Genomics, Government etc.)
Opportunities to work across a variety of laboratory environments (analytical testing, biotech, clinical trials, forensics, medical device, pharmaceutical, public health and research hospitals)
Comprehensive health and welfare programs to fit your individual or family's needs:Health Insurance
Dental Insurance
Vision Insurance,
401(k) Retirement Saving that includes a generous employer match
Paid Time Off (vacation, sick, holiday)
Company Paid Life Insurance
Company Paid Short and Long Term Disability Insurance
Wellness Plans and Rewards
Strong company values of team work, culture and values, personal and professional development, work-life balance, and recognition
Competitive compensation with opportunities to participate in employee bonus plan and travel bonus plan
At LabAnswer we offer a very competitive compensation package based on experience and education. We are looking for exceptional people to join our team, those who are looking to join an organization for the long term. We invite you to visit www.labanswer.com to review our Employee Value Proposition and Philosophy, and welcome you to apply, or refer a candidate to apply, through our careers page for employment consideration.